FDA 510(k) Application Details - K220470

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K220470
Device Name	Stethoscope, Electronic
Applicant	Shanghai Hulu Devices Co., Ltd No. 509 Caobao Road, Room 101-2 Building 9, Xuhui District Shanghai 200233 CN Other 510(k) Applications for this Company
Contact	Junfeng Zhao Other 510(k) Applications for this Contact
Regulation Number	870.1875   More FDA Info for this Regulation Number
Classification Product Code	DQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2022
Decision Date	05/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review